Europe – EMA adopts first list of critical medicines for COVID-19

On 7 June 2022, EMA’s Medicines Shortages Steering Group (MSSG) adopted the list of  critical medicines for the COVID-19 public health emergency . The medicines included in the list are authorised for COVID-19 and their supply and demand will be closely monitored to identify and manage potential or actual shortages.

Given the current stage of the pandemic, the published list contains all the approved vaccines and therapeutics in the European Union (EU) to prevent or treat COVID-19. It will be updated to reflect changes in the pandemic situation which may give rise to an increased risk of shortages of particular medicines, or following the authorisation of new medicines. The list does not replace national guidance on vaccination and the clinical management of COVID-19.

Marketing authorisation holders (MAHs) of medicines included in the list are required to regularly update EMA with relevant information, including data on potential or actual shortages and available stocks, forecasts of supply and demand. In addition, Member States will provide regular reports on estimated demand for critical medicines at national level. This will enable the MSSG to recommend and coordinate appropriate EU-level actions to the European Commission and EU Member States in order to prevent or mitigate potential or actual shortages of critical medicines to safeguard public health. EMA will liaise individually with the MAHs and national competent authorities to inform them of the timelines, processes and tools to collect the required information following the adoption of the list…